Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.

Tetanus Clinical Trial

Official title:

Phase IIIb, Multicentre Study to Assess Safety & Immunogenicity of GSK Biologicals' Combined DTPa/Hib (Infanrix/Hib) Vaccine vs Separate Administration of DTPa (Infanrix) & Hib (Hiberix) Vaccines in Healthy Infants 3,4,&5 Months of Age as Compared With the Separate Administration of DTPa and Hib Vaccines at Different Injection Sites.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412854
• Other study ID #: 104567
• Status: Completed
• Phase: Phase 3
• Start date: January 3, 2007
• Est. completion date: June 25, 2007

Study information

• Verified date: December 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and immunogenicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: June 25, 2007
• Est. primary completion date: June 1, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 90 Days to 120 Days

Eligibility

Inclusion Criteria:

• A male or female between, and including, 90 and 120 days of age at the time of the first vaccination,

• written informed consent obtained from the parent or guardian of the subject

Exclusion Criteria:

• Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate,

• Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Tetanus

Intervention

Biological:
• Infanrix™/Hib

• Infanrix

• Hiberix

Locations

Country	Name	City	State
China	GSK Investigational Site	Mengshan
China	GSK Investigational Site	Wuzhou

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

References & Publications (1)

Yan-Ping Li, Shumin Zhang, Qiang Ye, Qiming Hou, Yanan Li, Hong Li, Yinghua Xu, Xiao Ma, Youping Liu, Xiaoling Chen, Lirong Huang, Gunasekaran Ramakrishnan, Richard Zhao, Haiwen Tang, Olivier Van Der Meeren, Hans L Bock.Combined diphtheria-tetanus-acellular pertussis vaccine mixed with Haemophilus influenzae type b conjugate vaccine is safe and immunogenic in two studies in Chinese infants.Chinese Journal of Vaccines - Zhongguo Yi Miao He Mian Yi (Zhongguo Ji Hua Mian Yi). Zhongguo Yi Miao He Mian Yi. 2010 Apr;16(2):97-104

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)	A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (=) 0.1 international units per milliliter (IU/mL).	At Month 3
Primary	Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)	A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (=) 0.15 microgram/milliliter (µg/mL).	At Month 3
Primary	Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies	The vaccine response was defined as it follows: for PT and FHA, an antibody concentration higher than or equal to (=) 20 EL.U/mL at post-vaccination; for PRN, at least a 4-fold increase in antibody concentration from pre-vaccination to post-vaccination time points.	At Month 3
Secondary	Number of Subjects With Anti-PRP Antibody Concentrations = 1.0 µg/mL	The number of subjects with anti-PRP antibody concentrations higher than or equal to (=) 1.0 µg/mL post primary vaccination is reported.	At Month 3
Secondary	Concentrations for Anti-D and Anti-T Antibodies	Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL).	At Month 0 and Month 3
Secondary	Concentrations for Anti-PRP Antibodies	Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL).	At Month 0 and Month 3
Secondary	Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies	Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).	At Month 3
Secondary	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.	During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (=) 37.1 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.	During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
Secondary	Number of Subjects With Unsolicited Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.	During the 31-day (Day 0-30) follow-up period after each vaccination
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	From receipt of first dose of study vaccine (Day 0) to study end (Month 3)

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